1. Field of the Invention
This invention relates to a medical device. More specifically, this invention relates to a medical device for provision or delivery (infusion) of fluid and aspiration of fluid in relation to an operative field through an interchangeable probe operatively connected to such device. The interchangeable probe tip is coupled to a unique mount affixed to and/or incorporated into a handset of said device. This mount permits the rapid connection/disconnection of an interchangeable probe and freedom of orientation of the probe, relative to the handset, while preserving the sealing engagement thereof to the handset.
2. Description of the Prior Art
The provision of medical service involving surgical procedures has and continues to tax the limits of the health services industry, which includes the limited availability of skilled professionals to deliver such services and the individual's and insurer's ability/willingness to pay for extended periods of recovery in the supervised environment of a hospital. A prolonged recuperative period also causes potential economic hardship to the patient in the nature of lost earnings and exhaustion of medical benefits. Accordingly, there has and continues to be an emphasis on the delivery of health related services on an outpatient basis or by the adoption of techniques which reduce the burden on the health service industry and the patient. One such evolution has occurred in the surgical field through the implementation of "least invasive surgical" techniques (also hereinafter designed "LIS techniques" or "laparoscopy") in place of the traditional "open" or "large incision" oriented surgical procedures.
The rapid adoption and popularity of laparoscopy (surgery through micro incisions and with the aid of fiberoptics) is without precedent in modern surgical history. Surgeons throughout the world have eagerly embraced this operation, primarily because of the significant benefits in overall patient care that laparoscopic surgery offers.
Until recently, laparoscopy was performed strictly by gynecologists and not general surgeons or other specialists. During the late 1980's, this started to change when a general surgeon pioneering a new field began to perform cholecystectomy (removal of the gallbladder) laparoscopically. This technique quickly became the norm. With laparoscopic surgery gaining widespread acceptance, more and more procedures that were previously performed with conventional large, painful and temporarily disabling incisions, started being performed utilizing the laparoscopic modality. This field is still at a rapid growth rate. The need for new instruments to perform these procedures is great and the lack of such instruments is a limiting factor in the changeover from open to endoscopic surgical procedures.
Due to the lack of specifically designed instruments for general surgical laparoscopic procedures, new general surgical laparoscopists were forced to use existing gynecologic instrumentation. The predecessor to the modern medical device utilized in both laparoscopic and general surgery for infusion and aspiration of fluids were, thus, based upon devices originally designed for gynecological procedures. One instrument that was adapted for general surgical use was the "suction/irrigator." Various other electrosurgical instrumentation was also utilized. Electrosurgical instruments consisted of an insulated solid rod or hollow cannula with an exposed electrosurgical tip of several different configurations. These could be utilized to both bluntly and electrosurgically (cutting with electricity) to dissect the gallbladder from the liver bed. Electrosurgical energy can also be utilized to stop bleeding. Typically, cannula type electrosurgical instruments were equipped with one trumpet valve which was used for the evacuation of smoke (a byproduct of electrosurgery) that is created during electrosurgical dissection. The inherent protrusion of the extended tip from the electrosurgical instrument and the small internal diameter limited suction capabilities. Also, the Luer Lock connector utilized on these instruments would clog due to the Luer's small internal diameter and restrictive nature and thus waste surgical time. To switch back to a non-obstructive suction irrigation cannula was time consuming.
To satisfy the needs of the industry a symmetrical hand actuated trumpet valve which incorporated an interchangeable probe tip concept onto a laparoscopic suction/irrigator was developed. Prior to this, all suction/irrigators were one piece (the probe tip being permanently affixed to the handset or valve control body).
The instant invention as disclosed is a basic assembly which further facilitates endoscopic surgery. The invention of interchangeable, detachable probe tips is nowhere disclosed in the prior art. Because of the previous obscurity of laparoscopic surgical procedures (limited to gynecological procedures), the prior art has had little or no use for this type of instrument assembly beyond its original field of application, nor any need or incentive to modify it to accommodate a field of use that was as yet to emerge.
In order to gain perspective into the evolution of the field of laparoscopy and the techniques attendant thereto, it is initially necessary to first gain an appreciation of the instrumentation originally associated with this field. The valve body traditionally associated with laparoscopic instruments contained either two trumpet style valves or two stop cocks which were used to control suction and fluid flow. A cannula (hollow tube) was attached to the body which housed these valves. During laparoscopy, the cannula would be inserted into the abdominal cavity to enable suction and irrigation of fluids. Dependent upon physician preference, these cannula were configured either with or without holes on the tip and also were available in several lengths. A cannula with holes would enable more efficient suction of fluids and debris with less clogging. A cannula without holes allowed a physician to utilize water pressure as a dissecting force (i.e. hydro-dissection) and also allowed for the suction retraction of tissue. If, during a procedure, a different tip design was necessary, the total unibodied design handpiece with cannula was changed. Luer Lock connectors (utilized in the medical field for fluid connection) allowed for this, but with this design a new suction irrigator had to be used in order to utilize a different cannula, as Luer Lock connectors are an integral part of the valve. Thus, it necessitated complete trumpet valve disconnection prior to changing probe tip/cannula design (either length or tip configuration) and turning off the irrigation source during this changing period.
The symmetrical trumpet valve concept consists of a versatile instrument for control of suction and irrigation that allows the utilization of all types of cannula and probe tips, both insulated and non-insulated in conjunction with a valve body/handset of symmetrical design. Probes with varying diameters, lengths and also electrosurgical cannula are, thus, able to be adapted to a hand-held housing which could control suction and irrigation functions. These attachments are easily and expeditiously changed without interruption of either the suction or irrigation source. In connection with this purpose a threaded connection was developed. This concept allows utilization of many different attachments to one universal body.
However, threading and unthreading attachments is not as expeditiously accomplished as is possible. Threads can be misaligned and time can be wasted during the surgical procedure as attachments are changed. Because of the foregoing limitation, new methods for quickly attaching and detaching interchangeable probe tips and attachments to the body of the trumpet valve are needed. Furthermore, in order to fulfill the demanding requirement of the laparoscopic surgeon, a quick disconnect assembly which allows for 360 degree rotation of the attachment for varied orientation of electrosurgical tips during use in the surgical environment is further required. Such preference of the clinician for freedom of orientation need occur without rotation of the body of the trumpet valve. Additional requirements of the surgeon demand that this quick disconnect fitting will accommodate five or ten millimeter outside diameter cannula probe tips or electrosurgical attachments and permit coupling to either end of the symmetrical valve.
As is evident from the foregoing discussion, the increasing adaptation of laparoscopic surgical procedures to operations traditionally requiring a large incision has introduced a whole new set of demands and specifications for the instrument designer and the surgeon for whom it is designed. Up to now, those demands have been only partially fulfilled with the introduction of the trumpet valve; and there continues to exist need for improvement thereto to further enhance the versatility and ease of use of the trumpet valve by providing greater ease and speed of interchange of probe tips to the trumpet valve body.